Ten commandments of successful trial management.
A well-designed, adequately funded clinical trial based on sound science and conducted by experienced investigators and staff can falter if participating trial clinics are not managed well. Ten commandments for successful trial clinic management address key organizational and operational issues. Commandment I: Thou shalt know and follow thy rules. Commandment II: Thou shalt know and fulfill thy roles. Commandment III: Thou shalt meet thy commitments. Commandment IV: Thou shalt collaborate. Commandment V: Thou shalt communicate. Commandment VI: Thou shalt document. Commandment VII: Thou shalt honor thy participants. Commandment VIII: Thou shalt keep thy participants' secrets. Commandment IX: Thou shalt revere thy data. Commandment X: Thou shalt know and accept thy limitations. This report puts these commandments into context by providing concrete examples in the clinical trial setting. These commandments could serve as guidelines to the spectrum of personnel involved in the operations of a trial clinic, namely, principal investigators and co-investigators, trial coordinators, data managers, technicians, administrators, and support staff.
Margitić
S E
SE
Department of Public Health Sciences, Bowman Gray School of Medicine, Wake Forest University, Winston-Salem, North Carolina 27157-1063, USA. smargiti@rc.phs.bgsm.edu
Miles
N L
NL
D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D012106:Research / Q000458:organization & administration